Scapula Adaption in Overhead Athletes
Primary Purpose
Scapular Dyskinesis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intensive scapula-focused approach
Control Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Scapular Dyskinesis focused on measuring scapular dyskinesis, EMG biofeedback, scapulometer
Eligibility Criteria
Inclusion Criteria:
- (1) with scapular dyskinesis
- (2) overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools
Exclusion Criteria:
- if they have a history of shoulder pain or injury
Sites / Locations
- National Taiwan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive scapula-focused approach
Control therapy
Arm Description
Outcomes
Primary Outcome Measures
Change of range of motion after 4-week training
Passive interior rotation ROM and exterior rotation ROM of the glenohumeral joint will be assessed bilaterally using a hand-held standard universal goniometer. The player will lay supine with the humerus abducted to 90 degrees and elbow flexed to 90 degrees. The fulcrum of the goniometer is set at the olecranon process.
Change of muscle strength after 4-week training
The maximal isometric strength of 8 shoulder-scapula complex muscles will be assessed bilaterally using a handheld dynamometer. Each test will be performed twice, with a 30-second rest period between tests. The largest strength value for each muscle will be used for statistical analyses, normalized to body weight (in kilograms), and expressed as a percentage for inter individual comparison.
Change of shoulder complex kinematics after 4-week training
The Polhemus 3Space FASTRAK system (Polhemus Inc., Colchester, VT, USA) will be used to record shoulder complex kinematics.
Change of muscular activities after 4-week training
Bipolar surface electromyographic (EMG) electrodes will be placed over the upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) of the dominant shoulder to record muscular activities.
Secondary Outcome Measures
Forward shoulder posture (acromial distance)
The measurement of the distance between the posterior border of the acromion and the table (acromial distance) is performed in supine. In this position, the assessor measured the distance between the most posterior aspect of the posterior border of the acromion and the table bilaterally.
Pectoralis minor muscle length
The distance from the fourth rib to the coracoids process will be measured with FASTRAK system with accuracy of 0.08 cm. This distance (in centimeter) is divided by the subjects height and multiplied by 100. This results in a pectoralis muscle length index (PMI).
Full Information
NCT ID
NCT03568487
First Posted
May 30, 2018
Last Updated
November 3, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03568487
Brief Title
Scapula Adaption in Overhead Athletes
Official Title
Scapula Adaption in Overhead Athletes: Novel Scapulometer Development, Scapula Movement Adaption and Intensive Scapula-focused Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Previous studies have proposed various ways to assess scapular dyskinesis, but they were impractical in clinical setting or the validity was questioned. The novel scapulometer we developed can measure the prominence of scapular medial border and inferior angle. We would like to examine its reliability and validity in subjects with symptomatic scapular dyskinesis. The long-term, high-intensity, unilateral loading may cause overhead athletes to develop adaptive changes in shoulder kinematics, range of motion (ROM) and strength in the dominant arm. We hypothesized that these changes may be related to scapular dyskinesis. According to the previous studies, we expect electromyography (EMG) biofeedback training can help improve the ratio of muscle activation of scapular muscle.
Detailed Description
Fifty subjects of scapular dyskinesis will be classified and recruited from overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools and through local Internet media. All participants and their legal guardians will provide written informed assent and consent, respectively, and the study will be approved by the Ethics Committee Institutional Review Board. Since intervention may be specific to pattern of scapular dyskinesis, pattern of scapular dyskinesis in control group will match the pattern of scapular dyskinesis in the intervention group. Twenty-five subjects per group is based on a minimal revenant difference of a self-reported functional questionnaire between intervention and control (Struyf et al., 2013; Andersen et al., 2014). Participants will be recognized as elite players in their age categories. Subjects will be excluded if they have a history of shoulder pain or injury. Players will supply their player characteristics, including years of sports practice, weekly sports and conditioning exposure and type of sports. Players' standing height, sitting height, and body mass will be measured and used with the chronologic age to estimate their biological age according to the assessments of skeletal age, dental age, and secondary sex characteristics (Baxter et al., 2005). A clinical trial with a blinded assessor will be conducted. The subject takes a form (with a letter A or B) indicating allocation to either groups (scapula-focused approach versus control) from a closed envelop. For the scapula-approached group, pattern of scapular dyskinesis will be assessed. Then subjects in B control group will meet pattern-matched criteria related to pattern assessment of scapula-focused group. More subjects may be recruited for the control group to meet pattern-matched criteria of scapula-approached group. A list with subject numbers and the group allocation that results from this matched-control procedure will be stored in a sealed envelope. Only the therapist has direct access to the allocation list. In this way, subjects are allocated to either intervention or control group comprised of 25 subjects in each group. Both groups will be treated by the same therapist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scapular Dyskinesis
Keywords
scapular dyskinesis, EMG biofeedback, scapulometer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive scapula-focused approach
Arm Type
Experimental
Arm Title
Control therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Intensive scapula-focused approach
Intervention Description
scapula-focused approach with exercises, 3 x 20 min training per week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Control Therapy
Intervention Description
not have any physical training but is encouraged to stay active as usual.
Primary Outcome Measure Information:
Title
Change of range of motion after 4-week training
Description
Passive interior rotation ROM and exterior rotation ROM of the glenohumeral joint will be assessed bilaterally using a hand-held standard universal goniometer. The player will lay supine with the humerus abducted to 90 degrees and elbow flexed to 90 degrees. The fulcrum of the goniometer is set at the olecranon process.
Time Frame
Baseline and after 4-week training
Title
Change of muscle strength after 4-week training
Description
The maximal isometric strength of 8 shoulder-scapula complex muscles will be assessed bilaterally using a handheld dynamometer. Each test will be performed twice, with a 30-second rest period between tests. The largest strength value for each muscle will be used for statistical analyses, normalized to body weight (in kilograms), and expressed as a percentage for inter individual comparison.
Time Frame
Baseline and after 4-week training
Title
Change of shoulder complex kinematics after 4-week training
Description
The Polhemus 3Space FASTRAK system (Polhemus Inc., Colchester, VT, USA) will be used to record shoulder complex kinematics.
Time Frame
Baseline and after 4-week training
Title
Change of muscular activities after 4-week training
Description
Bipolar surface electromyographic (EMG) electrodes will be placed over the upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) of the dominant shoulder to record muscular activities.
Time Frame
Baseline and after 4-week training
Secondary Outcome Measure Information:
Title
Forward shoulder posture (acromial distance)
Description
The measurement of the distance between the posterior border of the acromion and the table (acromial distance) is performed in supine. In this position, the assessor measured the distance between the most posterior aspect of the posterior border of the acromion and the table bilaterally.
Time Frame
Baseline and after 4-week training
Title
Pectoralis minor muscle length
Description
The distance from the fourth rib to the coracoids process will be measured with FASTRAK system with accuracy of 0.08 cm. This distance (in centimeter) is divided by the subjects height and multiplied by 100. This results in a pectoralis muscle length index (PMI).
Time Frame
Baseline and after 4-week training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
(1) with scapular dyskinesis
(2) overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools
Exclusion Criteria:
if they have a history of shoulder pain or injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiu-Jenq Lin, PhD
Phone
02-33668126
Email
jiujlin@ntu.edu.tw
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiujenq lin
12. IPD Sharing Statement
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Scapula Adaption in Overhead Athletes
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